BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    INTERACOUSTICS

    MDR report key: 18292852 · Received December 8, 2023

    Report

    Report Number
    9710051-2023-00001
    Event Type
    Malfunction
    Date Received
    December 8, 2023
    Date of Event
    November 10, 2023
    Report Date
    November 27, 2023
    Manufacturer
    INTERACOUSTICS A/S
    Product Code
    GWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DURING A VESTIBULAR EXAMINATION A ROTATING OVERHEAD PROJECTOR WHICH IS PART OF THE EXAMINATION EQUIPMENT BECAME DETACHED FROM IT'S SUPPORT AND FELL, CREATING A "GASH" TO THE PATIENTS HEAD. THE PATIENT WAS SENT TO THE ER. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200189 INTERACOUSTICS ORION GWN INTERACOUSTICS A/S COMPREHENSIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other